MAUDE Adverse Event Report: BECTON DICKINSON 20ML SYRINGE LUER-LOK TIP; SYRINGE, PISTON

Model Number	303310
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Plastic syringe cracked as technician was drawing up chemo medication.Leading to drug leaking out of closed system transfer system.

• Brand Name: 20ML SYRINGE LUER-LOK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 21798358
• Report Number: MW5168719
• Device Sequence Number: 15696783
• Product Code: FRN
• UDI-Device Identifier: 00382903033102
• UDI-Public: (01)00382903033102
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 303310
• Device Lot Number: 4319956
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown